caring mill lidocaine aloe gel burn and pain relief

caring mill lidocaine aloe gel burn and pain relief
SPL v1
SPL
SPL Set ID 0ec20c87-1681-dd23-e063-6394a90a291c
Route
topical
Published
Effective Date 2024-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
water aloe vera leaf glycerin sodium hydroxide propylene glycol carbomer homopolymer, unspecified type phenoxyethanol polysorbate 20 caprylyl glycol allantoin panthenol lemon peel spearmint oil symphytum x uplandicum leaf .alpha.-tocopherol acetate 1,2-hexanediol ethylhexylglycerin fd&c blue no. 1 fd&c yellow no. 5

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-01-20

Purpose

External Analgesic

Description

Lidocaine Hydrochloride 0.5%


Medication Information

Warnings

For external use only

Avoidcontact with eyes

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again with a few days, discontinue use of this product and consult a doctor.

Uses

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations.

Purpose

External Analgesic

Directions

Adults and children 2 years of age and older. Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Consult a doctor.

Other Information

Store between 68°F to 77°F (20°C to 25°). May stain some fabrics or surfaces

Inactive Ingredients

Water, Aloe Barbadensis Leaf Extract, Glycerin, Sodium Hydroxide, Propylene Glycol, Glyceryl Acrylate/Acrylic Acid Copolymer, Carbomer, Phenoxyethanol, Polysorbate 20, Caprylyl Glycol, Allantoin, Panthenol, Citrus Limon (Lemon) Peel Extract, Mentha Viridis (Spearmint) Leaf Oil, Symphytum Officinale (Comfrey) Leaf Extract, Tocopheryl Acetate, 1,2-Hexanediol, Ethylhexylglycerin, Blue 1, Yellow 5.

Description

Lidocaine Hydrochloride 0.5%

Do Not Use

in large quantities, particularly over raw surfaces or blistered areas.

Drug Facts

Package Labeling:

Active Ingredients

Lidocaine Hydrochloride 0.5%

Keep Out of Reach of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

For external use only

Avoidcontact with eyes

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again with a few days, discontinue use of this product and consult a doctor.

Uses

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations.

Purpose

External Analgesic

Directions

Adults and children 2 years of age and older. Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Consult a doctor.

Other Information (Other information)

Store between 68°F to 77°F (20°C to 25°). May stain some fabrics or surfaces

Inactive Ingredients (Inactive ingredients)

Water, Aloe Barbadensis Leaf Extract, Glycerin, Sodium Hydroxide, Propylene Glycol, Glyceryl Acrylate/Acrylic Acid Copolymer, Carbomer, Phenoxyethanol, Polysorbate 20, Caprylyl Glycol, Allantoin, Panthenol, Citrus Limon (Lemon) Peel Extract, Mentha Viridis (Spearmint) Leaf Oil, Symphytum Officinale (Comfrey) Leaf Extract, Tocopheryl Acetate, 1,2-Hexanediol, Ethylhexylglycerin, Blue 1, Yellow 5.

Do Not Use (Do not use)

in large quantities, particularly over raw surfaces or blistered areas.

Drug Facts

Package Labeling:

Active Ingredients (Active ingredients)

Lidocaine Hydrochloride 0.5%

Keep Out of Reach of Children. (Keep out of reach of children.)

If product is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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